RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Regulated medical devices in the EU and US are classified according to risk, with Class I devices representing the lowest probable risk, and Class III medical devices representing the highest probable risk.

EC Health and Consumer Policy Spokesperson Frederic Vincent said that the Poly Implant Prothese (PIP) scandal "reinforces our opinion that we have to be tougher on medical devices, particularly class III."

Breast implants sold by PIP have been reportedly rupturing at an abnormally high rate, and further reports have indicated that the company used unapproved industrial grade silicone instead of the approved medical grade silicone.

Currently, medical devices in the European Union go through a less arduous approvals process than do pharmaceutical products, which need to prove both safety and efficacy to Europe's centralized regulatory body, the European Medicines Agency (EMA).

Medical devices are approved by the decentralized regulatory bodies of each Member State, and only need to show adherence to quality standards and safety before being sold to the public. Once a medical device has received marketing approval, it is the responsibility of each Member State to monitor the safety of the medical device. Vincent noted that new proposals could seek to make new recommendations for Member States to coordinate their activities more closely, as well as new recommendations regarding the use of notified bodies in order to prevent episodes like the PIP scandal from occurring again.

The new proposal would bring the EU's medical device regulations in to closer alignment with the US's Premarket Approval (PMA) system, which regulates medical devices that are determined to be "high risk"-usually Class III medical devices and some Class II devices-with a stricter level of scrutiny than devices cleared by the 510(k) program.

Medical devices cleared by the 510(k) program only need to show that they are "substantially equivalent" to predicate devices in order to be cleared.

It is unclear, however, if the proposed EC recommendations would have done much to stop the PIP scandal. "We are dealing with a case of fraud. It means that what happened in France could have happened even with a more stringent pre-market assessment of the products,"&nbsp;said Vincent.